DELSYM  COUGH RELIEF PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge 
Reckitt Benckiser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Delsym®
Cough Relief Plus Soothing Action

Drug Facts

Active ingredients (in each lozenge)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Menthol 5 mgOral pain reliever

Uses

temporarily relieves

Warnings

Sore throat warning

  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 6 years of age.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling develops
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

D&C red #33, FD&C red #40, flavors, isomalt, maltitol syrup, propylene glycol, sorbitol, sucralose, water

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack

NDC 63824-161-16

NEW!

Delsym®

COUGH RELIEF PLUS
SOOTHING ACTION

Dextromethorphan HBr 5 mg (Cough Suppressant)
Menthol 5 mg (Oral Pain Reliever)

16 LOZENGES

Sugar Free
Cherry

Principal Display Panel - 16 Lozenge Blister Pack
DELSYM   COUGH RELIEF PLUS SOOTHING ACTION
dextromethorphan hydrobromide and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C red no. 40 (UNII: WZB9127XOA)  
isomalt (UNII: S870P55O2W)  
propylene glycol (UNII: 6DC9Q167V3)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize27mm
FlavorCHERRYImprint Code D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-161-1616 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 3/2012
Document Id: 1d370013-c9fc-401e-9841-4afe29ee5aed
Set id: bc0334df-0f75-4be9-b922-f3e0fc7289a6
Version: 1
Effective Time: 20120314
 
Reckitt Benckiser LLC